TWN Info Service on Health Issues (Jan14/05)
29 January 2014
Third World Network

Dear Colleagues,

Below is an updated news reports on the discussion on Intellectual Property Flexibilities and Access to Medicines that took place at the WHO Executive Board last week.

Kindly ignore the version sent yesterday.

Sangeeta Shashikant
Third World Network

In WHO, South defends use of TRIPS flexibilities for public health

Alexandra Bhattacharya* (Geneva): Developing countries defended their right to use flexibilities allowed by the Agreement on Trade Related Aspects of Intellectual Property (TRIPS) of the World Trade Organization topromote access to affordable medicines as the WHO Executive Board discussed a draft resolution on access to essential medicines.

The 134th session of the Executive Board met in Geneva from 20 to 25 January 2014.  The Executive Board is composed of 34 Member States and meets twice a year to facilitate the work of the World Health Assembly.

The draft resolution titled “Access to essential medicines” was proposed by China, Libya, Republic of Korea and South Africa, and amongst one of its elements, encouraged the use of TRIPS flexibilities by Member Sates particularly with regard to the promotion to access to essential medicines.

The draft resolution was adopted by the EB and will be forwarded to the next World Health Assembly in May.

Plenary discussion on the draft resolution triggered a number of interventions by developing countries as the resolution comes at a time when multinational pharmaceutical companies are orchestrating a challenge to South Africa's legislative efforts to introduce IP policy reforms, which will promote access for medicines.

Namibia, on behalf of the African Region called on the WHO to support its member states in safeguarding the use of TRIPS flexibilities and stressed on the need for strong technical support in this context at country level. It also said that it “fully supported South Africa in its fight to increase access to medicines”.

[Recently various documents revealed that the Innovative Pharmaceuticals Association of SouthAfrica (IPASA) – a front organization of multinationals in the pharmaceutical sector in South Africa – and the US-based industry body PhRMA (the Pharmaceutical Researchers and Manufacturers of America) have engaged a consultancy firm Public Affairs Engagement (PAE) to subvert the South African intellectual property law reform process.

In September 2013, South Africa issued its draft national IP policy which proposes changing South Africa’s IP law to include a number of health safeguards including vigorous examination of patent applications, patent oppositions, limiting patent term to 20 years only, and adopting easy to use parallel importation and compulsory license mechanisms.

The PAE prepared a strategy for IPASA and PhRMA titled Campaign to Prevent Damage to Innovation from the Proposed Draft National IP Policy in South Africa. The Mail and Guardian reported this strategy on 17 January 2014.

In response to this revelation the South Africa Health Minister Aaron Motsoaledi accused a group of multinational pharmaceutical companies active in South Africa “of conspiring against the state, the people of South Africa and the populations of developing countries – and of planning what amounts to mass murder”, according to Mail and Guardian.]

At the Executive Board, South Africa in an emotional intervention called the strategy written by the PAE to undermine South Africa’s efforts to reform its Intellectual Property policies “unfortunate”, adding that the policy aimed at contributing “towards the protection and promotion of public health, and access to medicines in particular”.

This is not the first time that South Africa has been under such an attack, even in the face of the most devastating HIV/AIDS and TB co-morbidities, South Africa added.

[In 1998, 39 pharmaceutical companies filed a suit against the South African government over its Medicines and Related Substances Act. The main issue was Amendment 15(c) which would allow TRIPS-compliant compulsory licensing and parallel imports. In 2001 the pharmaceuticals companies, under an extremely high amount of international pressure, dropped their case.]

South Africa recalled that in 2000, the cost of combination antiretroviral therapy per person per annum was US$10 000, but in 2010, ten years later these costs had been reduced to USS$1 000 per person per annum, that is by 50%. This would not have been possible without generic competition, South Africa said, adding that South Africa has been able to put 2.4 million people on treatment.

Today around 4% of South Africans are on second line antiretroviral therapy (ART) but this number must be increased to 14% for those who have been on ART for more than 5 years, stressing that this will not be possible at current costs which are 2.5 times the cost of 1st-line therapy, emphasizing that  “We have to put people on treatment that is affordable”.

There are still other barriers to access, that requires attention in South Africa, it further said, stressing that the new IP policy under discussion will promote competition and ensure leveling of the playing field. Patent examination isamongst these policy reforms, and has been an important measure as reported in various reports by WIPO and WTO in partnership with WHO, South Africa further said. It stressed that it was common practise in Europe, US, India and Brazil to reject poor quality patents.

It also referred to WHO’s comment to South Africa on its draft IP Policy which said “WHO encourages and supports IP policies that maximize health-related innovations and promote access to medicines for all and commit to provide assistance consistent with GSPOA”.

Brazil said “access to medicine was a key element in our country” and stressed on the importance of the use of TRIPS flexibilities.

India referred to The Doha Declaration on TRIPS and Public Health which it said was  “very clear and unambiguous” in the right of member states to use, to the full, the provisions in the TRIPS Agreement, which provide flexibilities for public health, adding that the Declaration also reaffirms that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all."

India also noted that the declaration referred to all medicines and not just essential medicines and therefore it stronglysupported S. Africa “in its efforts to defend the spirit of Doha Declaration on TRIPS and Public Health so that it can provide access to medicines at an affordable cost."

Cuba, Argentina, Nigeria, Zimbabwe and Bolivia also expressed support for South Africa.

WHO's Director General, Margaret Chan said “I have been following the event in South Africa and I was very struck by what is happening and I have said so in other contexts and I will repeat again: no government should be intimidated by interested parties for doing the right thing in public health”. Chan thanked governments for their solidarity with South Africa, stressing that “nobody should be denied access to life-saving intervention or medical products.”

South Centre, and intergovernmental think tank for developing countries, expressed strong support to South Africa’s efforts “to improve access to medicines, particularly to the ongoing work undertaken to review its intellectual property legislation in order to integrate public health concerns into pharmaceutical patent examination.”

South Centre also recalled that history was repeating itself as 14 years ago, in the Executive Board developing countries and some developed countries supported the Government of South Africa when 39 pharmaceutical companies brought a court case against the South African Government over the terms of its Medicines Act.  It welcomed a message of support from the Executive Board to the Government of South Africa on its ongoing reform to their Patents Act.

South Centre added that it supports developing countries making use of their right to incorporate all the flexibilities contained in the WTO TRIPS Agreement in their intellectual property legislation and implement them in order to ensure theaccess of all peoples to necessary medicines.

M?decins Sans Fronti?res (MSF) said that the intersection between intellectual property, innovation and public health is recognized in a number of WHO resolutions and in the TRIPSAgreement and yet it remained  achallenge for WHO member states, especially developing countries, to use these flexibilities when drafting intellectual property policies that aim to promote access to affordable essential medicines. It added that the events in SouthAfrica last week illustrated that multinational pharmaceutical companies will go to great lengths to protect profit margins, even when it comes at the expense of people’s lives, and involves the covert derailing of government policies aiming to balance intellectual property, public health and access to medicines.  It underlined that such attacks on urgently needed reform are unacceptable in a country facing one of the world’s most acute HIV and TB epidemics, with medicine prices up to 35 times higher than countries with more robust generic competition.

No developed country made an intervention in defense of South Africa's policies.

Adoption of Draft Resolution on Access to Essential Medicines

After numerous informal meetings among Member states, the draft resolution came up for consideration at the final plenary session of the Executive Board.

In contention was operative Paragraph 11 of the draft resolution which urged Member States “to consider, as appropriate, adapting national legislation in order to make full use of the provisions contained in the TRIPS agreement, including the flexibilities recognized by the Doha Ministerial Declaration on the TRIPS agreement and Public Health and other WTO instruments related to TRIPS agreement, in order to promote access to essential medicines, as stated in the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property”.

US, a non-EB members objected to the use of the words “as stated in”, adding that it preferred the use of the term “ in accordance” which in its opinion, “frames proceeding language in full context of the Global Strategy”.

Egypt stated that the use of “ in accordance with” placed limitations on the member states with regard to the interpretation of TRIPS Agreement flexibilities.

Brazil, proposed “ in line with” as alternative wording. This was accepted by the EB Members with  Australia  commenting that as it was  under “some attack with regard to TRIPS flexibilities”( in reference to the on going challenges to its tobacco plain packaging legislation) and it preferred the use of “in line with”.

A NGO observer noted that operative paragraph 11 has limited utility as the scope of the resolution is limited to essential medicines and most of the medicines on WHO's Essential Medicines List (EML) are off patents. The observer also noted that several critical patented medical treatments do not make it to the EML due to the criteria of selection which includes "costs-effectiveness" . Consequently  since cost continues to be a key criteria for the selection of essential medicines, patented medicines with a high price tag tend not to be included to the EML. Recently, civil society organisations criticized WHO for the exclusionof two critical cancer medications I.e.  Trastuzumab for the treatment of breast cancer and Imatinib Meslate for the treatment Chronic Myeloid Leukemia (CML) from WHO ‘s 18th edition of essential medicine list. 

Further, the resolution is silent on the provision of adequate resource allocation to WHO’s essential medicine program. WHO’s medicine program is under funded and under staffed. Oxfam in a letter to Lancet dated January 2013 urged member states “(1) prioritise and restore the full range of activities that are needed to support Member States to manage medical products; (2) support, with adequate finance from the central WHO budget, medicines-related functions that require independence from the interests of individual donors; and (3) maintain and increase technical expertise in countries through the National Pharmaceutical Officers scheme to build national pharmaceutical capacity for universal health coverage”.

The Resolution on “Access to essential medicines” will now be discussed during the World Health Assembly which is expected to be held 19–24 May 2014.

[*With inputs from Alice Fabbri and Chiara Di Girolamo, WHO Watchers]